US regulators float ideas for boosting medical device safety

The plan from the Food and Drug Administration includes few immediate changes.

miércoles, 18 abr. 2018 04:30 pm

food and Drug Administration campus in Silver Spring, Md. U.S. health
officials proposed steps to improve the government’s system for overseeing
medical devices.

MATTHEW PERRONE Washington, US | April 17

U.S. health officials on Tuesday proposed steps to improve the government's system for overseeing medical devices, which has been criticized for years for failing to catch problems with risky implants and medical instruments.

The plan from the Food and Drug Administration includes few immediate changes, but lists a number of ideas and proposals with the goal of improving safeguards on pacemakers, artificial joints, medical scanners and other devices.

3 Decades since the FDA started the regulatory framework for devices.

Among other measures, the FDA will consider requiring more training for doctors who implant certain high-risk devices. But that step, like others floated by the agency, might require new guidelines or regulations. Other proposals may require additional money from Congress.

The FDA has repeatedly been forced to issue safety alerts about unexpected problems with devices that only appeared years after they were approved for use in patients. In the last decade, those have included hip replacements that failed prematurely, faulty wiring in implanted defibrillators, surgical mesh linked to pain and bleeding and a surgical instrument that inadvertently spread uterine cancer.

"We want to have better tools for detecting issues that occur postapproval," FDA Commissioner Scott Gottlieb said Tuesday. "But we also want to have better policies to quickly intervene and better inform patients and providers if we see adverse events happening." An agency critic said the report contains few concrete changes.

"FDA's safety strategies for medical devices are still years away from effective implementation," said Diana Zuckerman, president of the National Center for Health Research, a consumer advocacy group